| Class 3 Device Recall Orthofix Bone Marrow Aspiration Needle |  |
Date Initiated by Firm | October 18, 2010 |
Date Posted | December 10, 2010 |
Recall Status1 |
Terminated 3 on February 28, 2011 |
Recall Number | Z-0590-2011 |
Recall Event ID |
57011 |
510(K)Number | K913306 |
Product Classification |
Bone marrow collection/transfusion kit - Product Code LWE
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Product | Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle. |
Code Information |
Lot numbers L0J124, L0D175, L9K206 and L9E218 |
Recalling Firm/ Manufacturer |
Orthofix Inc 3451 Plano Parkway Lewisville TX 75056-9453
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Manufacturer Reason for Recall | Outer cartons for the product may be labeled with incorrect needle gauge. |
FDA Determined Cause 2 | Other |
Action | Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061. |
Quantity in Commerce | 274 |
Distribution | Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LWE
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